Deep Brain Stimulation Therapy and Intestinal Microbiota

Deep Brain Stimulation Clinical Trial

Official title:

Effect of Deep Brain Stimulation Therapy on Intestinal Microbiota in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855344
• Other study ID #: Ling Zhou
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Ling Zhou
• Phone: +8615895918786
• Email: lingzhou531[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. > 18 years of age;

2. Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr);

3. Deep brain stimulator therapy;

4. Sign the informed consent.

Exclusion Criteria:

1. Use of probiotics or probiotics during the study;

2. Use antibiotics against intestinal bacteria at present or within the last 1 month;

3. With cognitive dysfunction or mental illness;

4. With severe diseases or is not expected to survive for more than a year;

5. A history of gastrointestinal surgery;

6. AIDS patients, hepatitis B/C positive.

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Gastrointestinal Microbiome

Locations

Country	Name	City	State
China	the Hospital Research Ethics Committee of the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gut microbiota	Analyzed by 16sRNA sequencing of feces	Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Primary	Change in gut microbiota	Analyzed by 16sRNA sequencing of feces	Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary	Change in blood biomarkers of neuroinflammation and alpha-synuclein	Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein	Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Secondary	Change in blood biomarkers of neuroinflammation and alpha-synuclein	Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein	Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary	Frequency of defecation		Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Secondary	Frequency of defecation		Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary	Dosage of anti-Parkinson's agent		Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Secondary	Dosage of anti-Parkinson's agent		Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary	Change in the score of Unified Parkinson's Disease Rating Scales	It is consisted of six scales, each scale is graded on a scale of 5 (0-4), with zero being normal and 4 being severe.	Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Secondary	Change in the score of Unified Parkinson's Disease Rating Scales	It is consisted of six scales, each scale is graded on a scale of 5 (0-4), with zero being normal and 4 being severe.	Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary	Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)	Change in PDQ-39 scores, higher scores mean a worse outcome	Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Secondary	Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)	Change in PDQ-39 scores, higher scores mean a worse outcome	Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy